Balloon within balloon catheter system and methods of use

Abstract

A drug delivery system is described. The system has a first fluid delivery reservoir and a second fluid delivery reservoir. The first reservoir is separately controllable from the second reservoir. The first reservoir and second reservoir are attached to a manifold having a first solution channel in fluid communication with the first reservoir and a second solution channel in fluid communication with the second reservoir. The manifold is connected to a catheter having a first lumen in fluid communication with the first solution channel and a second lumen in fluid communication with the second solution channel. The catheter has a first balloon in fluid communication with the first lumen and a second balloon in fluid communication with the second lumen. The first balloon is located within the second balloon. The first balloon is not in fluid communication with the second balloon and the second balloon is perforated. A method for using the system and a kit containing the system are also described.

1 . A drug delivery system, comprising:
 a first fluid delivery reservoir of a first volume;   a second fluid delivery reservoir of a second volume;   a catheter having a proximal end, a distal end, a first balloon at the distal end and a second balloon at the distal end, wherein the first fluid delivery reservoir is in fluid communication with the first balloon and the second fluid delivery reservoir is in fluid communication with the second balloon, wherein the first balloon is located within the second balloon, wherein the first balloon is not in fluid communication with the second balloon, wherein the second balloon is perforated, and wherein the perforations in the second balloon are (1) smallest at the proximal end of the second balloon and increase in size incrementally towards the distal end of the second balloon and/or (2) at a lower numerical density at the proximal end of the second balloon and increase in numerical density incrementally towards the distal end of the second balloon.   
     
     
         2 . The drug delivery system of  claim 1 , wherein the first fluid delivery reservoir and the second fluid delivery reservoir are syringes. 
     
     
         3 . The drug delivery system of  claim 1 , wherein the first volume of the first fluid delivery reservoir and the second volume of the second fluid delivery reservoir are different. 
     
     
         4 - 5 . (canceled) 
     
     
         6 . The drug delivery system of  claim 1 , wherein the catheter comprises a strain-relief section at the proximal end. 
     
     
         7 - 8 . (canceled) 
     
     
         9 . The drug delivery system of  claim 1 , wherein the drug delivery system further comprises a housing that holds the first fluid delivery reservoir and the second fluid delivery reservoir. 
     
     
         10 . The drug delivery system of  claim 1 , wherein the second balloon is coated with, or comprises an embedded, drug or active ingredient. 
     
     
         11 . A method for treating a condition at a target location in a body lumen of a subject in need thereof, the method comprising:
 establishing an entry portal into the body lumen, introducing a guide wire through the entry portal to the target location;   directing the guide wire through the body lumen to the target location;   feeding a catheter along the guide wire, through the entry portal and to the target location; wherein the catheter is part of a drug delivery system that comprises:
 a first fluid delivery reservoir of a first volume; 
 a second fluid delivery reservoir of a second volume; and 
 the catheter, wherein the catheter comprises a proximal end, a distal end, a first balloon at the distal end and a second balloon at the distal end, 
 wherein the first fluid delivery reservoir is in fluid communication with the first balloon and the second fluid delivery reservoir is in fluid communication with the second balloon; wherein the first balloon is located within the second balloon, wherein the first balloon is not in fluid communication with the second balloon, wherein the second balloon is perforated, and wherein the perforations in the second balloon are (1) smallest at the proximal end of the second balloon and increase in size incrementally towards the distal end of the second balloon and/or (2) at a lower numerical density at the proximal end of the second balloon and increase in numerical density incrementally towards the distal end of the second balloon; 
   expelling a first physiologically acceptable solution from the first fluid delivery reservoir, thereby inflating the first balloon and occluding the body lumen at the target site; and   expelling a second physiologically acceptable solution from the second fluid delivery reservoir, thereby applying the second physiologically acceptable solution to the target site through the perforations in the second balloon, wherein the second physiologically acceptable solution further comprises a drug or active ingredient.   
     
     
         12 . The method of  claim 11 , wherein the body lumen is a blood vessel. 
     
     
         13 . The method of  claim 11 , wherein the body lumen is a lymphatic vessel. 
     
     
         14 . The method of  claim 11 , wherein the body lumen is selected from the group consisting of the small intestine, large intestine, esophagus, bile duct, pancreatic duct, urethra, ureter, bronchus, bronchiole, and sinus. 
     
     
         15 . The method of  claim 11 , wherein the condition is a varicose vein or spider vein. 
     
     
         16 . The method of  claim 11 , wherein the condition is a cancer. 
     
     
         17 . The method of  claim 11 , wherein the drug or active ingredient comprises a sclerosing agent. 
     
     
         18 . The method of  claim 17 , wherein the sclerosing agent comprises sodium tetradecyl sulfate or polidocanol. 
     
     
         19 . The method of  claim 17 , wherein sclerosing agent is applied to the target location as a foam. 
     
     
         20 . The method of  claim 11 , wherein the drug or active ingredient comprises a chemotherapeutic agent. 
     
     
         21 . A kit for a drug delivery system, the kit comprising:
 the drug delivery system of  claim 1 ; and a guide wire.   
     
     
         22 - 23 . (canceled)